Postpartum Etonogestrel Implant for Adolescents (PPImplant)

University of North Carolina (UNC)

Status and phase

Completed

Phase 4

Conditions

Contraception

Adolescence

Postpartum

Treatments

Drug: Contraceptive implant

Study type

Interventional

Funder types

Other

Identifiers

NCT01666912

PPI-12-0732

Details and patient eligibility

About

This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.

Enrollment

96 patients

Sex

Female

Ages

14 to 24 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adolescents ages 14-24 attending prenatal care
Greater than 20 weeks estimated gestational age
English or Spanish-speaking
Desire to use the contraceptive implant for contraception postpartum
Anticipated delivery of a healthy infant vaginally or by cesarean.

Exclusion criteria

Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including

current or past history of thrombosis or thromboembolic disorders
hepatic tumors (benign or malignant)
active liver disease
undiagnosed abnormal genital bleeding
known or suspected carcinoma of the breast (or a personal history of breast cancer)
hypersensitivity to any of the components of the contraceptive implant.
Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate

Characteristics that would preclude involvement after delivery:

Birth of a stillborn infant.
Maternal ICU admission after delivery
Maternal postpartum hemorrhage requiring blood transfusion
Prolonged hospital stay (>7 days) postpartum
Coagulopathy associated with the pregnancy
Severe pregnancy-induced hypertension
Fever >38 degrees C postpartum
Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial